NCT03516448Unknown3 期
Randomized, Double-Blind, Placebo-Controlled, Multicenter Expanding Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma (HCC) (After HCC Resection)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 352
- 主要终点
- OS （Overall Survival）
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or placebo
详细描述
- The first stage includes evaluation of subjects, to assess the inclusion criteria and exclusion criteria, based on the patients' preoperative imaging results, including tumor size, tumor characteristics, etc.
- In the second stage, subjects will return to the hospital 21 days following the baseline examination.The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 21 days after surgery
- The day of randomization will be defined as Day 0. Randomized subjects will return to the hospital and begin cycle 1 on the day of randomization (Day 0). and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion.
- Cycles will occur as follows: cycles 2, 3, 4, 5, and n will begin on days 42±3, 70±3, 98±3, 126±3, and 14+28（n-1)± 3, respectively.
- Based therapeutic drugs are Gan Fu Le
- the participant will receive medical inspection so as to observe and ensure drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Aged ≥ 18 years and ≤ 75 years old, male or female
- •Subject underwent resection of hepatocellular carcinoma (confirmed by pathology)
- •The tumor characteristics must meet the following:A single tumor with a maximum diameter >5cm ,Preoperative imaging, or Intraoperative visual observation.;
排除标准
- •Concomitant malignant tumor(s) in other systems is/are present
- •Tumor thrombosis in the branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery
- •The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy
- •The subject took Sorafenib prior to randomization
- •The subject took other study/investigational drugs 7 days prior to randomization
- •The subject took Kang Laike injection/soft capsule，or Jinke Huaier granule 7 days prior to randomization
- •The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases
- •The subject has history of investigational drug or similar drug allergy
- •The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present
- •The subject is pregnant, lactating, or urine pregnancy test result is positive
- •Baseline (post-resection) examination exist tumor recurrence or metastasis;
研究组 & 干预措施
the Tyroserleutide for injection
Active Comparator
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
干预措施: Gan Fu Le Tablets (Drug)
the Tyroserleutide for injection
Active Comparator
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
干预措施: Tyroserleutide for injection (Drug)
the placebo group
Placebo Comparator
the placebo Gan Fu Le Tablets，6 tablets,po,tid
干预措施: Gan Fu Le Tablets (Drug)
the placebo group
Placebo Comparator
the placebo Gan Fu Le Tablets，6 tablets,po,tid
干预措施: Placebo (Drug)
结局指标
主要结局
OS （Overall Survival）
时间窗: 3 years
The time from randomization to death due to any reason
次要结局
- RFS(Recurrence Free Survival)(3 years)
研究者
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